Identity
- Trade Name
- Resolute Integrity™ FDA UDI
- Generic Name
- Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated FDA UDI
- Device Name
- Stent RSINT30022W MicroTrac 3.00X22OTW FDA UDI
- Model / Reference
- RSINT30022W FDA UDI
- Description
- Stent RSINT30022W MicroTrac 3.00X22OTW FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00613994793393 FDA UDI
- PMA Number
- P110013 FDA UDI
- FDA Product Code
- NIQ FDA UDI
- GMDN Term
- Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 22.0 Millimeter FDA UDI
Category: Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
Resolute Integrity™ by Medtronic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated.
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Cleared under the same submission
P110013 also covers:
- Resolute Integrity™ — MEDTRONIC, INC.
- Resolute Integrity™ — MEDTRONIC, INC.
- Resolute Integrity™ — MEDTRONIC, INC.
- Resolute Integrity™ — MEDTRONIC, INC.
- Resolute Integrity™ — MEDTRONIC, INC.
- Resolute Integrity™ — MEDTRONIC, INC.
- Resolute Integrity™ — MEDTRONIC, INC.
- Resolute Integrity™ — MEDTRONIC, INC.
- Resolute Integrity™ — MEDTRONIC, INC.
- Resolute Integrity™ — MEDTRONIC, INC.
- Resolute Integrity™ — MEDTRONIC, INC.
- Resolute Integrity™ — MEDTRONIC, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (1)
- FDA UDI d998690c-55fe-43ca-8f64-9d01285adbb4 37 fields · synced May 30, 2026